2025-521216-19-00招募中3 期
A Global, Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety and Tolerability of NBI-1117568 in Adults with Schizophrenia
Neurocrine Biosciences Inc.10 个研究点 分布在 3 个国家目标入组 151 人开始时间: 2025年11月21日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 151
- 试验地点
- 10
- 主要终点
- Occurrence of AEs during the Open-Label Treatment Period
研究概览
简要总结
To evaluate the long-term safety of NBI-1117568 in adults with schizophrenia.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •≥18 and ≤65 years of age. Direct rollover participants must have been aged 18 to 65 (inclusive) at screening for the parent study.
- •Primary diagnosis of schizophrenia.
排除标准
- •Considered to be at imminent risk of suicide or injury to self or others.
- •Any unstable or poorly controlled medical condition or chronic disease
- •Any laboratory test results indicating clinically significant, poorly managed, or unmanaged undiagnosed disease.
- •Certain heart conditions or uncontrolled blood pressure.
- •History of epilepsy, seizures (except seizures during childhood caused by a fever), or convulsions.
- •Currently taking medications that are not allowed.
- •Pregnant or breastfeeding.
结局指标
主要结局
Occurrence of AEs during the Open-Label Treatment Period
Occurrence of AEs during the Open-Label Treatment Period
次要结局
未报告次要终点
研究者
Neurocrine Medical Information Call Center
Scientific
Neurocrine Biosciences Inc.
研究点 (10)
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